A Long-term Extension Study of Ustekinumab in Pediatric Participants

Inclusion Criteria:

• Must have completed the dosing planned in the primary pediatric ustekinumab study

• Benefit of continued ustekinumab therapy (that is, a clinical response or clinicalremission as defined in the primary study at the final efficacy visit of the primarystudy)

• Parent(s) (preferably both if available or as per local requirements), legalguardian(s) or their legally acceptable representative must sign an informed consentform (ICF) indicating that he or she understands the purpose of, and proceduresrequired for, the study and is willing to allow the child to participate in thestudy. Assent is also required of children capable of understanding the nature ofthe study (typically 7 years of age and older) as described in Informed ConsentProcess. An adolescent who signs the assent form will be given the opportunity tosign an adult ICF at a later visit when they reach the age of majority during thestudy to indicate that he or she understands the purpose of, and procedures requiredfor, the study and is willing to participate in the study

• Must be willing and able to adhere to the lifestyle restrictions specified in thisprotocol

• Females of childbearing potential must have a negative urine pregnancy test atenrollment and prior to study intervention administration

Exclusion Criteria:

• Are pregnant, nursing, or planning pregnancy or fathering a child

• Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 [COVID-19]) infection (test positive), or (b) suspected SARS-CoV-2infection (clinical features without documented test results), or (c) close contactwith a person with known or suspected SARS-CoV-2 infection: Exception: (i) may beincluded with a documented negative result for a validated SARS-CoV-2 test: obtainedat least 2 weeks after conditions (a), (b), (c) above (timed from resolution of keyclinical features if present, example, fever, cough, dyspnea) and (ii) with absenceof all conditions (a), (b), (c) above during the period between the negative testresult and the baseline study visit

• Taken any disallowed therapies as noted in the primary study, before the plannedfirst long-term extension (LTE) dose of study intervention

• Any condition for which, in the opinion of the investigator, participation would notbe in the best interest of the participant (example, compromise the well-being) orthat could prevent, limit, or confound the protocol-specified assessments

• Participants who receive a live vaccination may be permitted to remain in the study,if approved by the sponsor and study intervention is held for a period of timespecified by the sponsor. Receipt of a live severe acute respiratory syndromecoronavirus 2 (SARS CoV-2) vaccine (against the virus that causes CoronavirusDisease 2019 [COVID-19]) is not automatically an exclusion criterion and must bediscussed with the medical monitor